Interactive media for parental education on managing children chronic condition: A systematic review of the literature

Although some research has examined the use of games for the education of pediatric patients, the use of technology for parental education seems like an appropriate application as it has been a part of the popular culture for at least 30 years.

R E S E A R C H A R T I C L E Open Access

Interactive media for parental education

on managing children chronic condition:

a systematic review of the literature

Ali Annaim1*, Mia Lassiter1, Anthony J Viera2and Maria Ferris1

Abstract

Background: Although some research has examined the use of games for the education of pediatric patients, the use of technology for parental education seems like an appropriate application as it has been a part of the popular culture for at least 30 years The main objective of this systematic review is to examine the literature for research evaluating the use of interactive media in the education of parents of children with chronic conditions.

Methods: We searched the MEDLINE, PSYCHINFO, CINAHL, Cochrane database of systematic reviews and EMBASE databases from 1986 to 2014 seeking original investigations on the use of interactive media and video games to educate parents of children with chronic conditions Cohort studies, randomized control trials, and observational studies were included in our search of the literature.

Two investigators reviewed abstracts and full texts as necessary The quality of the studies was assessed using the GRADE guidelines.

Overall trend in the results and the degree of certainty in the results were considered when assessing the body of literature pertaining to our focused questions.

Results: Our initial search identified 4367 papers, but only 12 fulfilled the criterion established for final analysis, with the majority of the studies having flaws that reduced their quality These papers reported mostly positive results supporting the idea that parent education is possible through interactive media.

Conclusion: We found limited evidence of the effectiveness of using serious games and or interactive media to educate parents of children with chronic conditions.

Keywords: Parent education, Interactive media, Chronic condition

Background

The estimated number of children with chronic health

conditions in the United States is 15 to 18 million [1].

These large numbers of children rely on their caregivers

for the majority of their care and health management by

virtue of them being dependents The parent/caregiver

roles include learning about their child’s condition,

giving medications, ensuring that the child performs

procedures, and providing transportation to

appoint-ments with health care providers [2].

The number of adults, who have grown up with tech-nology, in particular interactive media such as computer-delivered education and video games, has been rising with each successive generation Although the use of computer-based technology and video games has been described as a means to teach children to self-manage conditions such as cancer, asthma, and diabetes, the state

of the literature on the use of interactive technology and/

conditions has not been well characterized [3–9] Such interventions have been described in the literature as

“serious games” [10] The goal of this systematic review of the literature was to identify and evaluate research that had used interactive media approaches to educate parents

* Correspondence:aaannaim@gmail.com

1Department of Medicine, Division of Nephrology and Hypertension,

University of North Carolina at Chapel Hill, 7021 Burnett-Womack, Chapel Hill,

NC 27599, USA

Full list of author information is available at the end of the article

© 2015 Annaim et al Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made The Creative Commons Public Domain Dedication waiver Annaim et al BMC Pediatrics (2015) 15:201

DOI 10.1186/s12887-015-0517-2

of pediatric patients with chronic conditions and their

relative effectiveness.

Methods

We conducted a review of publications using the

fol-lowing databases: MEDLINE, PsychINFO, CINAHL, and

EMBASE, and we reported the findings based on the

Preferred Reporting Items for Systematic Review and

Meta-Analyses (PRISMA) criteria [11] The search terms

used are presented in Table 1 Additionally, the Cochrane

database of systematic reviews was accessed, and an

re-view focused on interactive health communication

appli-cations acted as a source for additional articles that the

reviews examined [12] To be included in the review, an

article had to report data evaluating an educational

inter-vention using either interactive media or interactive games

for parents Any original research design was eligible The

titles of the articles were scanned to identify pertinent

studies for abstract evaluation based on the presence of an

educational intervention in the title Two authors

inde-pendently examined abstracts from the most relevant

arti-cles; any disagreement between the authors was settled by

a senior advisor They also performed reference chaining

using the discovered studies as a starting point They

fo-cused on the following research question (see Table 2).

The primary research question was: Does the use of

“ser-ious games” (games intended to educate) and/or interactive

media for parents improve health outcomes in children

with chronic conditions (e.g asthma, diabetes, chronic

kid-ney disease, cystic fibrosis, and cardiac abnormalities)?

They determined internal validity, potential for biases,

accuracy and appropriateness of the analysis and

applic-ability used in each study The overall quality of the study

was determined through an application of the GRADE

guidelines [13–19] They also determined the literacy level

of the tools used in these the studies using the

Flesh-Kincaid methodology.

Inclusion/exclusion criteria

Only observational studies, cohort studies, and

random-ized control trials were included in the final review.

They included studies that went as far as 1986, the

earli-est year that this topic was introduced in the literature

[20] For cohort and randomized trials, they did not

differentiate studies on the basis of time between

inter-vention and post-testing, when applicable The

partici-pants for the studies needed to include parents in the

exposure group.

Data extraction

The studies were examined and basic information was

extracted from each study For quantitative studies

data was collected on: (1) the sample size in the study;

(2) the composition of the study population; (3) the

measurement tool that used in the study; and (4) out-comes Further information on the potential for biases and analysis performed in each of the quantitative studies is presented in Additional file 1 as an evidence table.

Critical appraisal

Two co-authors critically appraised each manuscript based on previously established criteria to assess the size

of each study as well as potential biases, confounders, measurement precision, generalizability, and the mean-ing of the findmean-ings from the study The studies were evaluated using the GRADE methodology, using such things as risk of bias and inconsistency, to grade the studies as very low, low, moderate, and high quality [19].

If there was a disagreement existed on the quality assess-ment of a study, the study was discussed with a senior advisor until a consensus was reached on the grading of the study.

Data synthesis

Because of heterogeneity in interventions and study de-signs they did not attempt meta-analysis The overall trend in the results and the degree of certainty in the results were considered when assessing the body of literature pertaining to our focused questions.

Results

Our initial search identified 4367 papers, but only 12 ful-filled the criterion established for final analysis as noted

in Fig 1 Most of the studies that explored outcomes of knowledge and/or skill showed an improvement in these outcomes after implementation of their particular inter-vention (Table 3) The quality of the studies found varied greatly; the majority being very poor quality studies with only one high quality study (Table 4).

One study examined the level of knowledge that parents had regarding asthma and found an improvement in scores using the “serious game” that was presented in the study [5] This study did not control for child’s percentage

of life with the condition, so parents experience with the disease or knowledge base overtime was not evaluated (P = 0.06, [95 % Confidence Interval [22.71, 24.29]) The questions that were used to assess the knowledge

of the participants both before and following the interven-tion had a standard grade level that varied greatly.

One randomized study used human simulators for improving the knowledge and management of dia-betes by parents [21] Although this was a small cohort study, improvement in self-efficacy and knowledge were promising, no statistical significance was found This study did not include information on the child’s dis-ease duration.

The largest study we found was an observational study

that looked at the use of educational kiosks at various

pub-lic locations [22] This study’s participants found this form

of interactive media to be educational; 49 % of the first

time users who completed the exit survey, planned to discuss the topics presented through the kiosks with health providers Although the study did not specify the questions used within the kiosk, there was no association between

Table 1 Search terms: search strategies and key words

Database Search strategies and key words

Pubmed “(parent education) AND (chronic condition OR diabetes OR asthma OR Chronic kidney disease OR Cystic fibrosis OR Congenital heart

disease OR CANCER) AND (interactive media OR game OR interactive tool)”

parent education AND (chronic condition OR diabetes OR asthma OR Chronic kidney disease OR Cystic fibrosis OR Congenital heart disease OR CANCER) AND (computer OR software)”

“(parent* education OR parent learning) AND (chronic condition OR cancer OR diabetes OR CF OR congenital heart disease OR chronic kidney disease OR asthma OR chronic illness) AND (interactive media OR game* OR video games OR serious games)”

parent education AND (chronic condition)

(parent education) AND (chronic condition OR diabetes OR asthma OR Chronic kidney disease OR Cystic fibrosis)

(serious games OR game* OR interactive media) AND (chronic illness OR diabetes OR chronic kidney disease OR cystic fibrosis OR cardi*) AND (parent*)

PsychINFO 1 Computer Games/

2 Simulation Games

3 Games/

4 Exp Computers/

5 INTERNET/

6 4 ot 5

7 3 and 6

8 1 or 2 or 7

9 Video gam$.tw

10 Computer gam$.tw

11 Online gam$.tw

12 Online gam$.tw

13 Interactive gam$.tw

14 gamer$.tw

15 Gaming.tw

16 Digital gam$.tw

17 9 or 10 or 11 or 12 or 13 or 14 or 15 or 16

18 8 or 17

19 Double blind.tw

20 Random$.tw

21 Control.tw

22 19 or 20 or 21

23 18 or 22

EMBASE ‘video game’ OR ‘video games’/exp OR ‘video games’ OR ‘video gamer’ OR ‘video gamers’ OR ‘video gaming’ OR videogame OR

videogames OR videogamer OR videogamers OR videogaming OR‘computer game’ OR ‘computer games’ OR ‘computer gamer’ OR

‘computer gamers’ OR ‘computer gaming’ OR ‘online game’ OR ‘online games’ OR ‘online gamer’ OR ‘online gamers’ OR ‘online gaming’

OR‘game system’ OR ‘games system’ OR ‘gamer system’ OR ‘gamers system’ OR ‘gaming system’ OR ‘game systems’ OR ‘games systems’

OR‘gamer systems’ OR ‘gamers systems’OR ‘gaming systems’ OR ‘arcade game’ OR ‘arcade games’ OR ‘arcade gamer’ OR ‘arcade gamers’

OR‘arcade gaming’ OR playstation OR playstations OR ‘interactive game’ OR ‘interactive games’OR ‘interactive gamer’ OR ‘interactive gamers’ OR ‘interactive gaming’ OR gamer OR gamers OR ‘game console’ OR ‘game consoles’ OR ‘gaming console’ OR ‘gaming consoles’

OR‘digital game’OR ‘digital games’ OR ‘digital gamer’ OR ‘digital gamers’ OR ‘digital gaming’ OR ‘handheld game’ OR ‘handheld games’

OR‘handheld gamer’ OR ‘handheld gamers’ OR ‘handheld gaming’ OR‘console game’ OR ‘console games’ OR ‘console gamer’ OR

‘console gamers’ OR ‘console gaming’ OR multiplayer OR multiplayers OR gameplay OR gameplayer OR gameplayers OR gameplayingOR

‘game boy’ OR ‘game boys’ OR ‘game cube’ OR ‘game cubes’ OR nintendo OR xbox OR mmorpg OR atari OR ‘space invader’ OR ‘space invaders’ OR ‘death race’ OR ‘pac man’ OR battlezone ORastrocade OR ‘donkey kong’ OR coleco OR tetris OR ‘super mario’ OR ‘sonic the hedgehog’ OR ‘street fighter’ OR ‘mortal kombat’ OR pokemon OR frogger OR dreamcast OR ‘grand theft auto’ ORsega:ab,ti OR pong:ab,ti AND (‘parents’/exp OR parents OR ‘parent’/exp OR parent) AND (‘education’/exp OR education OR ‘learning’/exp OR learning)

“parent* AND (education/exp OR education) AND ((interactive AND media) OR interactive OR serious) AND games AND ((((chronic AND conditions) OR diabetes/exp OR diabetes OR asthma/exp OR asthma OR cancer/exp OR cancer OR congenital) AND (heart/exp OR heart) AND (disease/exp OR disease)) OR cf OR chronic) AND (kidney/exp OR kidney) AND (disease/exp OR disease)”

EBSCO “parent* education AND (chronic conditions OR cancer OR congenital heart disease OR diabetes OR asthma)”

CINAHL “(parent education OR parent learning) AND (games Or interactive media)” parent* AND (chronic illness OR diabetes OR ckd OR chronic

kidney disease OR cardiac OR cystic fibrosis) AND (interactive media OR game* OR serious games)

Web of

Knowledge

Topic = (parent* education) AND Topic = ((chronic condition OR diabetes OR asthma OR CKD OR CF)) AND Topic = (interactive or simulation) (parent* education) AND Topic = (user-computer interface)

Topic = (parent education OR parent*) AND Topic = (educate OR educating) AND Topic = (parenting OR disciplining) AND Topic = (chronic condition OR diabetes OR CKD OR chronic kidney disease OR asthma)

the ease of kiosk use and participant education level.

Almost half of the kiosk events (47 %) came from one

location (a fast food restaurant), which could have acted as

a source of selection bias since participants could have

different exposure level than those recruited in a library.

The next randomized study assessed the effect of in-tense therapy with dieticians, psychologists and providers

on the self-management skills of parents whose children were diagnosed with atopic dermatitis [23] The interven-tion showed improvement in medical treatment confi-dence by the caregivers, resulting in a greater reduction (although not statistically significant) in disease severity among the intervention participants compared to controls based on the SCORAD (a survey for scoring atopic dermatitis) This translated into a decrease of 20.5 points

in the intervention arm and 16.2 points in the control arm (p = 0.21, t = 1.27) To measure rumination, the authors relied on the Trier scale for measuring coping with dis-ease, but there are not actual values provided for the inter-vention and control arms of the study.

One randomized looked at the effects on a computer-based asthma education program on quality of life, peak flow measures, and parental knowledge [24] There was

no statistical difference between the intervention and control groups concerning asthma knowledge or asthma symptoms There was a small improvement 0.4 in the intervention versus 0.3 in the control group in terms of their correct responses to a questionnaire related to air

Fig 1 PRISMA flow diagram

Table 2 Population, intervention, comparator, outcome, time

allowed for outcomes, time of search of the literature, study

designs allowed (PICOTTS)

Population Parents of children with chronic illnesses (includes

asthma, diabetes, chronic kidney disease, cardiac abnormalities, and or cystic fibrosis)

Intervention Serious/educational game; interactive media

Comparator Parent’s knowledge about their child’s condition at

baseline or in control group Outcomes Markers of improved management of the child’s

disease; parental knowledge; disease severity;

health outcomes Time allowed for

interventions effect

Up to 1 year of time allowed between intervention and post-test if applicable

Time into the past

for the search

1986 was the furthest back in the literature for the search

Study designs

allowed

Cohort studies; RCTs; observational studies

Table 3 Synthesis table

Study authors Population, design, intervention (tools) and

Outcome

(Flesch-Kincaid Grade Level)

Assessment of Quality Fall AJ et al

1998 [5]

Population: 20 parents of children with asthma

Design: intervention (pre and post assessment)

Intervention: Interactive, computer-based program;

Outcome: Newcastle Asthma Knowledge

Questionnaire

10 parents showed improved performance;

3 parents showed no change;

4 parents showed declined performance

3 dropped out Test scores improved from 21.8 at baseline to 23.5 after the intervention (95 % CI of 22.71

to 24.29) p = 0.06

Intervention tool: n/a Outcome measure: Newcastle Asthma Knowledge Questionnaire ranged from 2.2 to 11.9 grade level

Mixed results study;

Fair quality study

Sullivan-Bolyai

et al 2012 [21]

Populations: Parents: (10 in pilot, 13 in focus

groups and 16 in intervention)

Design: Intervention (pre and post assessment)

Intervention: Interactive human patient simulators

Outcome: Change in Diabetes Awareness and

Reasoning Test

For Diabetes Awareness and reasoning: 16 point increase in intervention vs 16 point increase in control, (p = 0.94, F = 3.15)

Self-efficacy diabetes scores in intervention group increased by 8 points vs 6 point increase for control (p = 0.68, F = 0.17)

Hypoglycemia fear-survey showed a 5 point decrease in scores for the intervention group vs

7 decrease in controls (p = 0.87, F = 0.03), lower scores showed less fear of hypoglycemia

n/a The internal validity of the study was

good; randomization occurred in the pilot arm to limit potential confounders but small cohort that was randomized

Thompson

et al.[22]

Population: Inner city population at a library, a

Department of Motor Vehicles office, and a fast

food chain location 20–25 % of the population in

the area was under the age of 14, 49–65 % had a

high school education or less for adults, and

26–32 % of the parents were single

Intervention: Use of an information kiosk

Outcome: Interest in using the information

provided from the sessions 1846 sessions of

informational kiosk use

1447 session of the interactive kiosk (47 % at the fast food chain location; 35 % at the public library; 18 % at the DMV)165 of the 250 respondents who completed the exit survey found the information from the kiosk useful;

113 respondents said they plan to talk with their physicians about the information from the sessions

Fair quality observational study; Skew

of results from one site but large sample population Lack of statistical analyses results for associations is concerning

Wenninger

et al 2000 [23]

Population: 129 families of children with Atopic

Dermatitis

Intervention: Combination of psychological

counseling in addition to clinic visits

Outcome: Disease severity, Quality of Life of the

parents, and coping skills of parents and patients

Severity of Atopic Dermatitis (SCORE-AD scores) decreased by 20.5 points in intervention vs 16.2 points in control (t = 1.27, p = 0.21) Confidence in medical treatment in the intervention arm (F = 7.96 of MANOVA, P < 0.01) Coping skills surveyed showed decreased rumination in the intervention group (t =2.44,

p < 0.05)

Good internal validity of the study, but concerned about the lack of tables comparing the baseline characteristics

of the intervention and control groups within the study

Huss et al

2003 [24]

Population: children with asthma

Intervention: Computer based asthma education

program

Outcome: Disease severity, Patient quality of life,

Disease knowledge

No difference in asthma knowledge between the intervention and control group Intervent group had a 0.4 point improvement on Air Control testing vs control groups 0.3 points improvement (95 % CI,−0.3 to 1.1) p >0.05)

No significant changes found in pulmonary

N/A Fair internal validity for the study, but

analysis did not mention controlling for asthma severity Lack of actual statistical values for some analyses is concerning

Table 3 Synthesis table (Continued)

function tests.No significant change in responses to Asthma Knowledge Questionnaire Guendelman

et al 2002 [25]

Population: 134 children with Asthma

Intervention: An interactive health learning device

Outcome: Limitation in physical activity, use of

health services, peak flow readings

19/62 intervention and 26/60 control children had peak flow readings in yellow or red zone (OR = 0.43, (0.23,0.82) p = 0.01); 20/62 intervention and 28/60 control children reported limitations

in physical activity (OR = 0.52 (0.29,0.94) p = 0.03);

4/62 intervention and 1/60 control children had

a hospitalization during study period (OR = 0.99 (0.25,3.88) p = 0.96); 6/62 intervention and 11/60 control children had an ED visit (OR 0.59 (0.25, 1.35) P = 0.21)

N/A Good internal validity with allocation

concealment and randomization

Shegog et al

2001 [26]

Population: 71 urban, minority children with asthma

Intervention: Computer-based asthma education

program

Outcome: Disease knowledge, self-efficacy

Intervention group had an improvement in their knowledge scores (21.1, 95 % CI [19.38

to 22.82] p <0.01)Self-efficacy showed an improvement in the intervention group (mean 56.5, 95 % CI [53.38, 59.62] p = 0.04)

N/A Fair study, analysis did not try to

control for disease severity or child’s performance in school

Horan et al

1990 [27]

Population: 20 adolescents with Diabetes

Intervention: Computer based program to educate

and monitor diabetes

Outcome: Hemglobin A1c percentages,

bloodglucose levels, disease knowledge

Disease knowledge improved in 60 % of intervention and 50 % of control children Improvement in blood glucose in the intervention group prior to lunch (F = 10.922,

p < 0.02) and prior to dinner (F = 7.221, p < 0.025)

N/A Poor internal validity, selection bias

introduced through matching without controlling being performed in the analysis

Dragone et al

2002 [28]

Population: 31 children with leukemia

Intervention: CD-ROM based education program

for cancer

Outcome: Sense of control through health locus

of control survey

Intervention group had an improvement in their survey results (r2= 0.33, F = 6.38, p = 0.004)

CD-ROM program reading level 5.5

Good internal validity study, analysis did not try to control for parental education level

Krishna et al

2003 [29]

Population: 228 children with asthma

Intervention: Internet-enabled interactive media

asthma education program

Outcome: Disease knowledge, caregiver Quality of

Life

Intervention groups showed improved disease knowledge (2.52, 95 CI [−0.38, 5.42], p = 0.029)Quality of Life scores showed no difference between the groups

Fair internal validity, quality of life had a small recall interval and no attempts to control for caregiver education through analysis

Homer et al

2002 [30]

Population: 106 high risk urban children with asthma

Intervention: Multimedia software for asthma

education

Outcome: Number of ED visits and acute office

visits, parent knowledge of disease, child

knowledge of disease

Intervention and control groups had reduction in

ED visits (2.14 to 0.86 in intervention group, 2.24

to 0.73 in control) with no statistical difference between the groupsParent knowledge (score of

80 in intervention and 78 in control) was no statistically different between the groupsChild knowledge improved both groups (F =18.78, p <

0.001)

N/A Good internal validity, randomization

protocol was well explained and data analysis tried to adjust for possible confounders

Swallow et al

2014 [31]

Population: 41 parents of children with CKD stage

3–5, 30 children with CKD stage 3–5

Intervention: Online parent information and

support program

Outcome: Parent management of disease, parent

empowerment, father’s level of support

Parents in the intervention showed improvement in perceived competence in managing their child’s condition vs control (2.6,

95 CI (−1.6,6.7) P = 0.213)Intervention parents had

a slight decrease in empowerment (−0.2, 95 % CI (−0.5, 0.2) P = 0.404)Father support level showed

an decrease in score (−4.3, 95 % CI (−24.7, 16.2)

P =0.667) among the intervention group

Online intervention Reading level 11.6

Fair internal validity, lack of adjustment for potential confounders in analysis

Possible selection bias

Table 4 GRADE quality evaluation

Study Initial quality based

on study design

evidence rating Fall et al 1998 Observational study–

Low quality (2)

Large Magnitude of effect: Not present in this study No reason to increase the grade (0)

Dose–response gradient: Not present in this study No reason to increase the grade (0)

All plausible confounders or other biases increase our confidence in the estimated effect: There is a possibility that parents received education after their child had been hospitalized, which would have reduced the effect seen (+1)

Risk of Bias: Very serious, concern about selection process used and vague inclusion criteria (−2)

Inconsistency: The confidence interval showed no true overlap between the pre and post-test scores No reason to down grade since the internal consistency did not appear to be in doubt (0)

Indirectness: Indirect measures, looking at knowledge of parents

Reasonable to downgrade (−1)Imprecision: Confidence Interval is not narrow and there is a small sample size Reasonable to downgrade (−1) Publication bias: Small observation study, Likely to have publication bias (−1)

Very low (1)

Sullivan-Bolyai,

et al 2012

Randomized control

trial: High quality (4)

Large Magnitude of effect: Not present (0) Dose–response gradient: Not present (0) All plausible confounders or other biases increase our confidence in the estimated effect: Not present (0)

Risk of Bias: Serious risk, lack of blinding and proper allocation concealment (−1)

Inconsistency: Serious inconsistency, low p-values with small F-values, indicating possible intragroup variability (−1)Indirectness: Serious indirectness, study looked at self-efficacy and knowledge, no mention

of patient-centered outcomes (−1) Imprecision: Unable to appropriately determine confidence intervals given the limited information provided in the paper Down-grade given the small sample size and the minimal improvement in scores when experimental compared to control arm (−1)

Publication Bias: Small pilot study, like to have publication bias since other studies with negative findings are not likely to be published

Reason to downgrade (−1)

Very low (1)

Thompson

et al 2007

Observational study–

Low quality study (2)

Large Magnitude of effect: Not really present in this study No reason to increase grade (0)

Dose–response gradient: Not really present in this study No reason to increase grade (0)

All plausible confounders or other biases increase our confidence in the estimated effect: Not really present in this study No reason to increase grade (0)

Risk of Bias: Serious risk of bias; concern about the fact that a majority of the data came from one location, additionally concern about the selection within the population regarding those who visit the locations where the kiosks were located (−1)

Inconsistency: Confidence intervals that were presented were narrow, and showed an effect that was consistent No reason to downgrade (0) Indirectness: Very indirect measures; looking at possibility of using the information instead of actually seeing if the information presented in the kiosks would be used (−2)

Imprecision: Confidence intervals were narrow and consistent Sample size is large, so it is reasonable to capture patterns No reason to downgrade (0)

Publication Bias: Study is rather large, and the findings are a reasonable mixture of positive and negative findings No reason to down-grade (0)

Very Low (1)

Wenninger

et al 2000

Randomized control

trial–High study

quality (4)

Large Magnitude of effect: There was not a large magnitude of effect noted (0)

Dose–response gradient: Not really present in this study No reason to increase grade (0)

All plausible confounders or other biases increase our confidence in the estimated effect: Not likely in this study No reason to increase grade.(0)

Risk of Bias: No serious limitations, low risk of bias from some of the key areas No reason to downgrade (0)

Inconsistency: Results were consistent, and the statistical F values showed

a reasonable effect No reason to downgrade (0) Indirectness: Study employed a scale to measure disease severity, although this was not translated to direct clinical outcomes The study also looked at quality of life and coping skills, rather indirect measures (−1) Imprecision: The results, although positive, showed some variability through the t-scores for the disease severity scale, which may include the change in scores seen in the control group Consider downgrading

Low quality study (2)

Table 4 GRADE quality evaluation (Continued)

for imprecision (−1) Publication Bias: No reasonable for publication bias, results showed some effect, although some of them were not statistically significant there is some clinical utility to them (0)

Huss et al

2003

Randomized control

trial–High quality (4) Large Magnitude of effect: Not present in the study No reason toupgrade (0)

Dose–response gradient: Not present in the study No reason to upgrade (0)

All plausible confounders or other biases increase our confidence in the estimated effect: This is possible given that since the confounding of asthma severity may cause residual biases against an effect Reasonable to slightly rate up (+1)

Risk of Bias: Serious risk of bias There was a lack of appropriate accounting of patients There also is some selective reporting of outcomes (no real information on absolute symptom reduction)

Reasonable to downgrade (−1) Inconsistency: The estimate of effect was consistent with findings in other studies Additionally there is some concern about the lack of appropriate controlling for possible confounders Reasonable to downgrade (−1) Indirectness: Study did try to measure disease severity through symptoms, although this is mixed in with some knowledge measures that were rather indirect Would slightly downgrade for the indirect measures (−1) Imprecision: The confidence intervals are wide with some overlap between the effect seen in the intervention and the control groups

Reasonable to downgrade (−1)

Publication Bias: The mixed nature of the results The study was published in a reasonable journal No reason to downgrade (0)

Very low quality study (1)

Guendelman

et al 2002

Randomized control

trial- High quality (4)

Large Magnitude of effect: Not truly present in this study No reason to upgrade (0)

Dose–response gradient: Not truly present in this study No reason

to upgrade (0) All plausible confounders or other biases increase our confidence in the estimated effect: The possibile confounders of asthma severity would have worked in the direction of the effect, so there is no reason to upgrade the rating (0)

Risk of Bias: Low risk of bias from a few of the key criteria There was good allocation concealment in place, although there was some loss to follow-up of some participants No reason to downgrade (0)

Inconsistency: No reason to downgrade Results are consistent throughout the study, and they are similar to other studies (0) Indirectness: The study looked at disease severity, actual symptoms, ED visits, and missed days of school These are very direct measures of the clinical effect of disease No reason to downgrade (0)

Imprecision: The confidence intervals for several of the odds ratios are wide It is reasonable to downgrade for the repeatedly wide confidence intervals (−1)

Publication Bias: No reason for possible publication bias given the thorough nature of the study (0)

Moderate quality study (3)

Shegog et al

2001

Randomized control

trial- High quality

study (4)

Large Magnitude of effect: Not present in the study, so no reason

to increase the grading (0) Dose–response gradient: No present in this study No reason to increase the grading (0)

All plausible confounders or other biases increase our confidence in the estimated effect: The difference between the intervention and control group, on the basis of asthma severity was not statistically significant, although this clear difference in terms of numbers would have made the intervention arm more likely to have issues with asthma, and likely more education This confounding factor would have worked with the intervention, so there is no reason

to increase the grade (0)

Risk of Bias: Serious risk of bias There is concern about the use of allocation concealment in the study, as well as the randomization procedure used for the study (−1)

Inconsistency: The results seem to be consistent throughout the study

No reason to downgrade (0) Indirectness: Indirect measures of knowledge were used, without any correlation to disease outcomes Would downgrade (−1)

Imprecision: The confidence intervals were narrow, although there is some overlap between the intervention and control groups’ intervals in the knowledge based assessments This overlap raises some question about the imprecision (−1)

Publication Bias: No reason to consider publication bias The results were

a mixture of positive and non-significant results (0)

Very low Quality study (1)

Table 4 GRADE quality evaluation (Continued)

Horan et al

1990

Randomized control

trial with

matching-High quality study

Large Magnitude of effect: Not present in this study (0) Dose–response gradient: Not present in this study (0) All plausible confounders or other biases increase our confidence in the estimated effect: The slight difference in disease knowledge at base line (more knowledge in the intervention group) would have supported the effect seen instead of working against the seen effect No reason to increase grade (0)

Risk of Bias: Serious risk of bias There is concern about the selection bias introduced through the matching process It is reasonable to downgrade (−1)

Inconsistency: The reasonably large F values show solid internal consistency for the study No reason to downgrade (0) Indirectness: There was a direct clinically pertinent measure in this study, blood glucose levels However, there was some indirect measures as well, knowledge and problem-solving There is reason to downgrade (−1) Imprecision: The F values show some reasonable effect with slower intragroup variability No reason to downgrade (0)

Publication Bias: No reason to consider publication bias The results had some reasonable support of their internal consistency through their F-values The effect seen was small but reasonable

Low quality study (2)

Dragone et al

2002

Randomized control

trial- High quality

study (4)

Large Magnitude of effect: Not present in this study (0) Dose–response gradient: Not really present in this study (0) All plausible confounders or other biases increase our confidence in the estimated effect: The confounders that may be present would work with the effect seen in the study, so there is little likelihood that this effect would be an underestimation (0)

Risk of Bias: No serious risk for bias There are slight issues with the measurement tools No serious reason to downgrade (0) Inconsistency: Internal consistency seems to rather solid give the high F-values Results are consistent with other studies, and they are supported by internal consistency No reason to downgrade (0) Indirectness: Very indirect measures were used, looked at mental understanding of disease and knowledge (−2)

Imprecision: The high F-values support the strength of the analysis that was performed There is minimal concern for the precision of analysis (0) Publication Bias: The results were mixed in nature, not showing much change in the events from the interviews and modest effect for knowledge No reason to consider publication bias (0)

Low quality study (2)

Large Magnitude of effect:

Dose–response gradient:

All plausible confounders or other biases increase our confidence in the estimated effect:

Risk of Bias:

Inconsistency:

Indirectness Imprecision:

Publication Bias:

Krishna et al

2003

Randomized control

trial- High quality

study (4)

Large Magnitude of effect: There was a small effect seen in terms

of knowledge scores that improved (0)Dose–response gradient:

There was no dose–response curve as all the intervention groups received the same degree of intervention No reason to increase the rating (0)

All plausible confounders or other biases increase our confidence in the estimated effect: One potential confounder that may be present, caregiver education, would work to minimalize the effect that is seen, so we could be slightly more confident in the effect that is seen (+1)

Risk of Bias: No serious concern for risk There is some minimal concern about the measurements used, but this does not provide enough reason

to downgrade (0) Inconsistency: Although the confidence intervals are narrow, there is overlap in several of the confidence intervals between the control and intervention groups This raises some concern about the internal consistency of the study (−1)

Indirectness: There was an appropriate mixture of indirect measures, knowledge scores, with clinically relevant outcomes, steroid dosage and emergency department visits No reason to downgrade given the use of several clinically important outcomes (0)

Imprecision: The confidence intervals that were presented appear to be sufficiently narrow No reason to downgrade (0)

Publication Bias: The results were mostly positive, yet the study was thorough and included clinically relevant outcomes, so the risk of publication bias seems minimal The impact of the journal that published the study would argue that the study was rigorous evaluated No reason

to downgrade

High quality study (4)

Table 4 GRADE quality evaluation (Continued)

Homer et al

2002

Randomized control

trial- High quality

study (4)

Large Magnitude of effect: There was not that large of an effect seen in the study The betas that were determined did not show that strong of a relationship No reason to increase the grading (0) Dose–response gradient: There was a slight dose–response gradient seen in some of the regression models that were performed (+1)

All plausible confounders or other biases increase our confidence in the estimated effect: The possible confounders in the study were included in the analysis of variance Since they were incorporated into the analysis, it seems difficult to see them working against

or for the effect seen No reason to increase the grade (0)

Risk of Bias: Serious risk of bias There is some serious concern about the different sites used for recruitment, different clinical settings with possibly different patient populations served Reasonable to downgrade (−1) Inconsistency: The large F-value shows some small intragroup variability to support the internal validity of the study No reason to downgrade (0) Indirectness: There is a mixture of indirect measures, knowledge, and several clinical outcomes, emergency department visits and asthma severity scores There is slightly more indirect measures, so there is some reason to downgrade slightly (−1)

Imprecision: There is concern about the precision in the study There is no clear way to look at regression analyses that were performed The analysis

of variance did show some reasonable intragroup study precision

Reasonable to downgrade for imprecision (−1)

Publication Bias: There is little reason to consider publication bias The results included some non-significant and significant findings that appeared to be appropriate No reason to downgrade (0)

Low quality study (2)

Swallow et al

2014

Randomized control

trial- High quality

study (4)

Large Magnitude of effect: There was not a large effect seen in this study (0)

Dose–response gradient: There was not a clear dose–response gradient observed in this study (0)

All plausible confounders or other biases increase our confidence in the estimated effect: There was the confounder of socioeconomic status, which showed the intervention group having a lower socioeconomic status This would have worked against the effect,

so our confidence that in the effect seen would be increased (+1)

Risk of Bias: Serious concern about selection bias introduced through the lack of blinding in the study Also concerned about the handling of missing data in the analysis Reasonable to downgrade (−1)

Inconsistency: There is great variability in the intraclass coefficients presented

in the study Reasonable to downgrade for some concern about the internal consistency of the study (−1)

Indirectness: Serious concern about the indirect measures that were used

in the study, looking at the results of surveys and scales to assess parental management ability and father support (−1)

Imprecision: The confidence intervals that are presented appear to vary widely, with overlap between the control and intervention groups

Reasonable to downgrade for precision in the study (−1) Publication Bias: The study was thorough, including some positive and non-significant findings There seems to be little reason to downgrade for publication bias (0)

Very low quality study (1)